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510(k) K861304

FAGAN TEST MACHINE FOR INFANT INTELLIGENCE by Infantest Corp. — Product Code LQD

K861304 is an FDA 510(k) premarket notification submitted by Infantest Corp. for the device "FAGAN TEST MACHINE FOR INFANT INTELLIGENCE". The FDA issued a decision of Substantially Equivalent on September 23, 1986. The device falls under product code LQD (Recorder, Attention Task Performance), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1986
Date Received
April 7, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Recorder, Attention Task Performance
Device Class
Class U
Regulation Number
Review Panel
NE
Submission Type

Other clearances for product code LQD

  • K173915 — Test of Variables of Attention (T.O.V.A.) (March 22, 2018)
  • K170082 — Test of Variables of Attention (T.O.V.A.) Version 9.0 (May 17, 2017)
  • K143468 — QbCheck (March 22, 2016)
  • K141865 — DANA (October 15, 2014)
  • K133382 — QB TEST (March 24, 2014)
  • K122149 — QBTES (October 17, 2012)
  • K040894 — QBTEST (June 22, 2004)
  • K020800 — OPTAX SYSTEM (June 10, 2002)
  • K911938 — DYNAVISION 2000 (August 2, 1991)
  • K854903 — GORDON DIAGNOSTIC SYSTEM MODEL I (June 2, 1986)

FDA data resources